Companies setting up a pharmaceutical manufacturing facility in the UAE don’t just secure a commercial license and start production. They first have to follow specific regulations through a set pathway. That involves getting approval for the facility, fulfilling the technical requirements, maintaining GMP compliance, undergoing inspections, obtaining professional licensing, and approvals from all relevant authorities.
This comprehensive guide provides an overview of the licensing process in the Emirates. That includes knowing the legal requirements, fees, timelines, GMP checks, and more associated with pharmaceutical manufacturing facilities.
Regulatory Body of Pharmaceutical Manufacturing Facilities in the UAE
The Emirates Drug Establishment (EDE) is the federal authority that regulates medical products in the UAE. They also cover pharmaceutical establishments and medical-product manufacturing facilities. This body takes care of manufacturing drugs, registering products, offering market authorization, inspection, and related regulatory activities.
Federal Decree-Law No. 38 of 2024 is the current framework that provides legislation and decrees for Medical Products, Pharmacists, and Pharmaceutical Establishments. It came into effect on January 2, 2025.
Important Note for Manufacturers
Older UAE pharmaceutical-facility guidance may refer to the Ministry of Health and Prevention (MOHAP). This is because pharmaceutical-facility licensing procedures were historically provided through MOHAP. Current EDE service pages and regulatory materials now provide the applicable federal services and requirements and may mention MOHAP and related websites in the process.
Licensing Regulations for Pharmaceutical Manufacturing Establishments in the UAE
For pharma manufacturing facilities, the relevant provisions are set out in Chapter Seven, “Licensing Medical Product Factories and Contracting Companies Manufacture Medical Products,” beginning with Articles 126-133. They are laid down below:
Article 126—License Conditions
The conditions state that no person can run medical product factories without a license from the EDE. They need to have a valid GMP certificate from the EDE. The license applicant or their legal representative should be the factory’s owner and legally responsible for compliance with EDE’s instructions and legislation.
Import, export, marketing, or distribution in the state will happen through an EDE license. Additionally, executive regulations of this decree law specify technical, health, and other requirements to be fulfilled. Follow applicable rules regarding UAE citizen participation and employment, where required. Factories located in free zones may be exempt from certain ownership requirements, depending on the applicable rules.
Article 127—Quality Management & GMP
Medical product manufacturers and contract manufacturing companies must comply with quality management standards and Good Manufacturing Practice requirements issued or approved by the EDE.
Article 128—License Term & Renewal
The factory license must be valid for at least one year and can be renewed. The license holder must apply for renewal within 60 days before its expiry according to the conditions.
If the renewal application is not submitted within 90 days after the license expires, the license may be automatically cancelled, and an administrative fine may apply. If the license is expired, the facility shouldn’t continue manufacturing.
Article 129—Moving or Transferring the Factory
A factory or contract manufacturing company cannot move to another location or make changes to the approved factory layout or plan without obtaining prior approval from the EDE. The ownership of the factory or company may be transferred to another person or entity. However, it is possible only with EDE approval and in accordance with the conditions specified in the Executive Regulations.
Article 130—Prohibitions
A medical product factory or contract manufacturing company must not:
- Carry out activities that are not covered by its license.
- Remanufacture an approved medical product with new technical specifications without obtaining the required new marketing approval.
- Manufacture or distribute counterfeit, defective, or unusable products.
- Deal with unlicensed pharmaceutical establishments.
- Begin installing medical products before obtaining the required GMP certificate.
- Carry out any other activity prohibited under the Executive Regulations.
The owner of the factory or company is responsible for violations of these requirements.
Article 131—License Suspension & Precautionary Closure
The EDE may temporarily suspend the factory’s license if, for example, the following happens:
- Ownership is transferred without EDE approval.
- The factory is moved without EDE approval.
- Qualified personnel are not available to supervise and control the operations.
- Forged documents were used.
- The company deals with unlicensed pharmaceutical establishments.
- Other circumstances specified in the Executive Regulations apply.
The EDE may also order immediate precautionary closure if the factory’s continued operation could pose a risk to public health. After suspension or precautionary closure, the matter must be referred to the EDE Pharmaceutical Practices Control Committee within seven working days. The committee must consider the case and decide on disciplinary responsibility within the period specified by the law.
Article 132—License Cancellation
The EDE may cancel the factory’s or contract manufacturing company’s license if the company carries out activities for which it is not licensed. The license or marketing approval obtained using forged documents or incorrect information will also be cancelled. The factory remaining closed for more than three consecutive months without an acceptable reason will receive this.
Other cancellation instances are when the factory does not begin operations within six months from the date of receiving its license without an acceptable reason. The company repeatedly violates GMP requirements. It does not correct violations within the period specified by the EDE. It commits certain serious prohibitions listed under Article 130.
Other cancellation conditions under the Executive Regulations apply.
Article 133—Display of the Product Price
For medical products subject to official pricing, the manufacturer or contract manufacturing company must clearly display the EDE-approved public selling price on the product’s outer packaging before the product is sold or delivered.
The packaging must also identify the factory or contract manufacturing company mentioned in the product’s marketing approval as the importer in the UAE, where applicable. The company may appoint a licensed medical warehouse to carry out these responsibilities, subject to the applicable requirements.
The factory owner and responsible persons may be held jointly responsible if the approved public selling price is not displayed correctly on the outer packaging.
Licensing Process for Pharmaceutical Manufacturing Facilities in UAE
The UAE licensing process applies to pharmaceutical establishments that sell pharma products and medical supplies and import, register, distribute, export, re-import, or manufacture them. Here’s how the process goes:
Step 1: Log in & Apply
Log in to the MOHAP website or smart app using the UAE Pass. Apply to get a pre-licensing approval for the facility. The local citizen owner will be issued an approval.
Step 2: Initial Inspection Requirements
Request an initial inspection and pay a fee for it. After the inspection is approved, the applicant should submit the initial approval request. Finalize the license requirements from government departments that are relevant. Apply for staff licensing (pharmacists).
Step 3: Final Inspection
Apply for the final inspection and pay the necessary fee. After it is approved, submit the final approval request along with the remaining documents. The license fee will be paid if the application is approved.
Step 4: Issued License
The license will be issued electronically and sent via email. Companies can also download it from the website.
Documents Required for a Pharmaceutical Manufacturing Facility
According to the EDE licensing guidance, establishing a pharmaceutical or medical device manufacturing facility involves three main stages. Take a look at them below:
1. Initial Approval
For the initial approval of a manufacturing facility, the applicant must submit the following:
- Memorandum and Articles of Association (MOA/AOA)
- Project feasibility study
- Partnership contract showing the ownership of capital
- Passports of all partners
- Family book for UAE national partners
- National ID cards of the partners
- Photographs of each partner
- Required introductory/security clearance information for each partner
The initial approval is issued after the required document review and security clearances. The approval is valid for six months and may be extended upon request.
2. Construction and Facility Preparation
After receiving initial approval, the manufacturer must obtain approval for the facility’s detailed engineering drawings before construction. The drawings should demonstrate elements such as material flow, personnel flow, and other GMP-related technical requirements.
The following documents are also required:
- Ministry of Industry approval for the manufacturing project
- Planning department or municipality approval
- Water and electricity department approval
- Municipality approval related to sanitation
- Environmental pollution-related approvals
- Approved detailed engineering drawings
- Technical agreement with international expertise houses
- List of pharmaceutical dosage forms or medical devices to be manufactured
- List of production lines
- List of equipment and devices for production, packaging, and sterilization lines
- Details of equipment required for the quality-control laboratory
Once these requirements are submitted, the facility can proceed toward the GMP certification inspection.
3. Final Licensing and GMP Certification
Before final approval, the facility must appoint appropriately qualified technical personnel, including a technical manager, production manager, and quality control manager. The EDE document also specifies that the facility must submit the following:
- Site Master File
- Technical Manager appointment letter, notarized employment contract, and professional license
- Production Manager appointment letter, notarized employment contract, and professional license
- Quality Control Manager appointment letter, notarized employment contract, and professional license
- Copies of licenses of staff working at the facility
- List of employees in each department and their responsibilities
The facility then undergoes the final inspection. Once the inspection and documentation requirements are satisfactorily completed, the final manufacturing facility license can be issued.
Average Service Timeline for Licensing Medical Product Facilities
When initiating the licensing process for pharmaceutical and medical device manufacturing facilities, several critical steps must be followed. Here’s a breakdown of the timeline for each stage:
- Pharmacies, warehouses, marketing offices, warehouses for re-export: 3 working days
- Primary Approval: within 5 days from the application receiving date
- Inspection team to audit compliance with GMP: 10 days from the date the request was received
- Issuance of compliance certificate with c-GMP: 5 days from the date of generation of the visiting report
- MOHAP facility license issued after completing fees/ documents: 3 days from the date of receiving the last requirement.
(All working days)
Fees for Pharmaceutical Manufacturing Facility Licensing in the UAE
Payments are required at different intervals throughout the approval process. These include the following:
- Application Fee: AED 100
- Initial Inspection Fees According to the Facility Type: AED 1000 per inspection for warehouses, pharmacies, and marketing offices
- Final Inspection Fees According to the Facility Type: AED 1000 per inspection for warehouses, pharmacies, and marketing offices
- Final License Fees According to the Facility Type: AED 7,500 for pharmacies & warehouses, AED 10,000 for marketing offices & export warehouses
- Manufacturing Facilities of Pharmaceuticals & Medical Devices: AED 100 for application fee, AED 3000 per inspection for final inspection fee, AED 2000 approval fee for architectural plans & drawings, and final licensing fees of AED 50,000.
Additional Approvals Required for Pharmaceutical and Medical Product Manufacturing Facilities
Apart from the licensing and certifications mentioned above, these facilities must also secure approvals from other government agencies. These approvals will help ensure comprehensive compliance and operational readiness. Here are the key agencies involved and their respective roles:
Ministry of Interior: Responsible for granting approval for the Introductory Statement of the Subjected Facility’s Owner(s), a vital step in establishing the ownership structure of the facility.
Departments of Economic Development: Involved in the registration of the trade name and issuance of the trade license, essential for conducting business operations legally.
Ministry of Health and Prevention: Manages the licensing of medical professionals and pharmacists.
Civil Defense: Issues the Civil Defense Certificate
Ministry of Climate Change and Environment (MOCCAE): Responsible for issuing the Environmental Compliance Certificate
Collaboration with these government agencies is important to get the necessary approvals and ensure full compliance with regulatory requirements.
Renewal of Pharmaceutical Manufacturing Facility License in the UAE
The factory license must be renewed annually, contingent upon adherence to good manufacturing practices (GMP) as verified by inspection teams. Facility owners can submit an official request to renew GMP certificates issued by EDE two months before the license expiry date to ensure timely completion.
Renewal dates are not linked to inspection visits. Failure to renew the license before expiry may result in legal action. Corrective measures must be taken based on feedback from inspection teams regarding GMP.
Documents Required for Renewal
According to the current EDE service information, applicants should submit the following:
- A copy of the valid industrial license
- Valid professional licenses for the Production Manager, Quality Assurance Manager, and Quality Control Manager
- A valid GMP certificate
- Environmental permit that’s valid
- A valid Civil Defence certificate
The application is submitted electronically through the EDE service portal. The current service information lists a processing time of approximately three working days, subject to fulfillment of all requirements.
Manufacturers should submit the renewal application before the existing license expires. Continuing to operate after expiry without renewal may result in legal action under the applicable legislation. Facilities must also complete the corrective measures required in response to GMP inspection observations
Conclusion
Navigating the licensing process for pharmaceutical manufacturing facilities requires careful planning, documentation and compliance with applicable regulatory requirements. For support with pharmaceutical regulatory compliance, GMP, registration and market-entry requirements, explore Artixio’s pharmaceutical compliance consulting services.
Contact us today to learn more about how Artixio can assist you in achieving regulatory compliance and market success in the UAE. Connect at info@artixio.com.
FAQs
1. Is a GMP certificate required to obtain a pharmaceutical manufacturing facility license in the UAE?
Yes. A pharmaceutical manufacturing facility must obtain a valid Good Manufacturing Practice (GMP) certificate from the Emirates Drug Establishment (EDE). The facility must also comply with applicable quality, technical, health, and manufacturing requirements before the final licence is issued.
2. Which technical personnel must be appointed at a pharmaceutical manufacturing facility?
The facility must appoint appropriately qualified and licensed personnel for key technical roles, including the Technical Manager, Production Manager, Quality Assurance Manager, and Quality Control Manager. The facility must submit its appointment letters, employment documents, professional licenses, and details of their responsibilities during the final licensing stage.
3. Does a pharmaceutical manufacturing facility license need to be renewed?
Yes. A pharmaceutical manufacturing facility license must be renewed in accordance with the applicable EDE requirements. The renewal application generally requires a valid industrial license, valid professional licenses of the relevant technical personnel, a valid GMP certificate, an environmental permit, and a Civil Defence certificate. Continuing operations after the license expires without renewal may result in legal action.
